Exactech Recalls Optetrak Knee Trays Due to Potential Mislabeled Components
Exactech is recalling specific Optetrak knee replacement trays because they may be mislabeled. The recall covers 16 units distributed in the US and several international countries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies the hazard as potential mislabeling without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving labeling errors or low-risk contamination.
Plain-English summary
Exactech, Inc. is recalling the Optetrak Cemented Trapezoid Tibial Tray (Sizes 1F/1T, 2F/1T) and the Optetrak Rotating Bearing Knee Tibial Tray (Finned, Cemented, Size 2F/1T). The recall is being conducted because these specific trays have the potential to be mislabeled. The affected products are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement or revision of failed previous reconstructions.
The recall involves 16 units with serial numbers ranging from 2067442 to 2067457. These devices were distributed worldwide, including in the United States (specifically California, Massachusetts, Ohio, and Oklahoma) and in Brazil, Colombia, France, Italy, Japan, Luxembourg, and Spain. The FDA has classified this recall as Class II, which means the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients who have received these specific tibial trays should contact Exactech, Inc. for further instructions on how to handle the recalled devices. Patients who have already had these trays implanted should consult with their orthopedic surgeon to discuss the potential implications of the mislabeling and determine if any further action is necessary.
The recalled product
- Product
- Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***". The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature…
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 16
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial number range 2067442 - 2067457.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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